Genetic Toxicology - Mammalian Cell Mutagenicity

Study Information
Study Attribute	Value
CEBS Accession Number:	002-02088-0009-0000-9
Chemical Name:	Diphenhydramine hydrochloride
CASRN:	147-24-0
NTP Study Type:	Genetic Toxicology - Mammalian Cell Mutagenicity
NTP Study ID:	590709
Study Result:	Negative

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Table Instructions and Notes:
Studies are indicated to be "Nontoxic" when the observed reductions in relative total growth did not indicate that the maximum tolerated dose was achieved.

Nonactivation Trial: 1 Experiment Call: Equivocal
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	104	91	94	30	30
			110	98	105	32
			102	103	89	29
			91	108	75	27
Test Chemical	Diphenhydramine hydrochloride	20	100	72	103	35	35
			88	77	89	34
			91	70	96	35
		30	96	54	92	32	30
			92	51	79	29
			90	71	82	30
		40	88	49	71	27	32
			101	54	98	33
			91	51	96	35
		50	100	34	117	39	33
			89	41	90	34
			94#	50	72	26
		60	99	40	95	32	35
			74	37	70	32
			87#	32	108	42
		80	58	9	105	61	59*
			71	9	129	60
			78	10	131	56
Positive Control	Methyl Methane Sulfonate	5	94	52	477	169	168*
			67	32	351	174
			85	48	407	159

Nonactivation Trial: 2 Experiment Call: Negative
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	109	118	127	39	39
			103	94	114	37
			110	83	127	38
			110	105	142	43
Test Chemical	Diphenhydramine hydrochloride	20	91	49	78	29	29
			78	49	61	26
			72	50	69	32
		30	104	64	86	28	32
			83	59	90	36
			107	43	105	33
		40	94	53	55	19	23
			109	43	71	22
			102	53	83	27
		50	156r	49	136	29	33
			101	32	118	39
			95	41	76	27
		60	109	37	122	37
			123r	23	99	27
			121r	40	113	31
		80	104	12	72	23	25
			102	9	108	35
			110	15	55	17
		100


Positive Control	Methyl Methane Sulfonate	5	56#	32	447	265	328*
			42	21	550	442
			69	30	574	278

Nonactivation Trial: 3 Experiment Call: Negative
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	102	88	93	30	29
			116	103	91	26
			107	81	111	35
			112	128	88	26
Test Chemical	Diphenhydramine hydrochloride	40	120	64	59	16	21
			113	45	93	28
			109	60	63	19
		50	113#	40	64	19	20
			94	41	58	21
			96	38	61	21
		60	110	41	57	17	20
			99	38	63	21
			116	40	76	22
		70	97	19	77	27	25
			104	19	82	26
			87	19	56	22
		80	114	19	57	17	17

			108	23	55	17
		100	105	7	76	24	21

			111	6	61	18
		120


Positive Control	Methyl Methane Sulfonate	5	55	21	408	248	219*
			89	37	454	171
			66	31	473	239

Induced S9 Trial: 1 Experiment Call: Inconclusive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	86	87	125	48	34
			91	96	85	31
			96	120	81	28
			95	97	85	30
Test Chemical	Diphenhydramine hydrochloride	10	94	123	85	30	28
			119	160	79	22
			94	105	88	31
		20	102	117	158	51	48
			82	103	104	42
			77#	96	119	51
		30	87	103	82	32	33
			94	101	88	31
			98	99	104	35
		40	88	108	61	23	28
			91	107	92	34
			86	100	72	28
		60	97	91	101	35	32
			105	92	105	33
			93	94	75	27
		80	99	105	72	24	32
			92#	88	88	32
			107#	83	130	41
Positive Control	3-Methylcholanthrene	2.5	74	43	839	380	384*
			86	46	848	330
			62	42	824	443

Induced S9 Trial: 2 Experiment Call: Negative
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	107	110	91	28	33
			105	107	119	38
			117	58	139	39
			120	124	99	28
Test Chemical	Diphenhydramine hydrochloride	25	109	86	151	46	41
			117	104	133	38
			117	87	133	38
		50	122r	75	101	28	32
			117	73	96	27
			100	78	111	37
		75	136r	56	95	23
			131r	58	71	18
			119	45	110	31
		100	124r	30	115	31	23
			90	14	57	21
			114	42	86	25
		150


Positive Control	3-Methylcholanthrene	2.5	117	68	986	281	308*
			102#	61	982	320
			98	50	948	324

Induced S9 Trial: 3 Experiment Call: Negative
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	90	107	102	38	38
			100#	126	84	28
			98	100	73	25
			57	66	105	62
Test Chemical	Diphenhydramine hydrochloride	30	112	104	127	38	37
			106	97	128	40
			93	103	96	35
		40	111	102	104	31	39
			86	58	114	44
			84	100	102	41
		60	123r	77	139	38	32
			101	69	98	32
			111	82	103	31
		80	100	61	112	37	38
			124r	61	136	37
			100	50	114	38
		100	105	23	97	31	32
			108	18	122	38
			90	13	77	28
		120


Positive Control	3-Methylcholanthrene	2.5	96	61	917	320	286*
			95	62	822	288
			97	83	726	249

Footnotes:
Asterisks(*) indicate significant responses.
r = rejected value due to quality control criteria
# = reduced sample size because of the loss of one culture dish due to contamination